Office of Compliance

The mission of the Center for Devices and Radiological Health (CDRH), Office of Compliance (OC) is to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices, the safety of radiological products, and enforcing the Federal Food, Drug, and Cosmetic Act and implementing regulations. We proactively engage the regulated industry and the research community through many avenues of education and public interaction to foster understanding of relevant laws and regulations to promote and maximize voluntary compliance.

OC has four operating divisions and several program areas. Two divisions are tasked with various areas of regulatory enforcement, one is tasked with bioresearch monitoring responsibilities, and one consolidates functions such as registration and listing, recalls, export certificates, and liaison with the Office of Regulatory Affairs and their district offices. Additional program functions include import/export, promotion and advertising, labeling, training, and risk management.

 

Contact OC

Food & Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3521
Silver Spring, MD 20993

Office of the Director
Phone: 301-796-5500

Program Management Office
Phone: 301-796-5500

Division of Enforcement A
Phone: 301-796-5770

Division of Enforcement B
Phone: 301-796-5540

Division of Bioresearch Monitoring
Phone: 301-796-5490

Division of Risk Management Operations
Phone: 301-796-5530